Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Senior Manufacturing Science & Technology Specialist

Your tasks and responsibilities

The primary responsibilities of this role, Senior Manufacturing Science and Technology Specialist, are to: 

  • The incumbent is responsible for process development, scale-up, technology transfer, establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft- chews, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms, working closely with Manufacturing, Engineering, and Quality organizations. Leading the development/engineering studies and batches and generating technical protocols, reports, manufacturing documentations and performing risk based assessments to detect quality and technological risks;
  • Manages and controls the development of each project’s work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct;
  • Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters. Understands the product and process complexity and supports Validation and  Quality  in  establishing the testing/characterization requirements for various process steps and overall manufacturing process validation;
  • Develops an understanding of product stability (physical and chemical) to guide design of studies in support of product registration and regulatory submissions;
  • Serve as single point of contact for internal teams and external customers as transfer lead for all product transfers.  Provide proper levels of customer service, but ensuring Bayer’s interests are maintained. Act as key interface with internal and external resources as needed to facilitate the transfer of process knowledge to the manufacturing environment;
  • Lead Project Team that includes: a project team of internal and external staff in support of Product Transfers;
  • Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities;
  • Support MFG efficiency and operations projects by interfacing with all internal departments (Quality Assurance, Engineering, Information Technology, Validation, Manufacturing, Planning, and Supply Chain Management). Troubleshoot challenges associated with process technology;
  • Interact with regulatory agencies during audits and process reviews

 

Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Bachelor’s Degree in Industrial Pharmacy, Pharmaceutics, Chemical Engineering or scientific field with minimum of five years of industry experience OR Master’s Degree with minimum of three years of experience;
  • The candidate must have familiarity with processing equipment and technologies utilized in Good Manufacturing Practices(GMP) manufacturing facilities for solids, soft- chews, non-sterile liquids or injectable  platforms  (at  least  in  1 areas).
  • A good understanding of Current Good Manufacturing Practices (cGMP) compliance requirements;
  • Experience in leading technical cross-functional teams or relevant technical project management experience;
  • The ability to lead, manage, motivate, and direct professional technical personnel relative to changing priorities, sense of  urgency,  and utilization of multiple skill sets;
  • The incumbent must demonstrate high levels of value and integrity. They must instill company visions, values and beliefs in others by example;
  • A thorough knowledge of current pharmaceutical technology, project implementation practices and the ability to analyze problems is necessary in order to effectively direct  the  activities  of  his/her project team;
  • Ability to prepare technical documents;
  • Strong communication skills and computer literacy.

Preferred Qualifications:

  • Process Technology Development experience preferrably in product transfers and optimization.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: KS-Shawnee Mission
Functional Area: [sap_fa_2]
Entry Level: 5